Kyle Blithe was 49 in August 2009 when she was implanted with a Cook Celect blood clot catching device to prevent another blood clot from reaching her lungs, a condition called pulmonary embolism. She could never have expected the device to fracture inside her body and cause further trauma.
Cook Medical’s Cook Celect is an IVC filter, a tiny metal device that is implanted in the inferior vena cava, a large vein inside the body that carries deoxygenated blood from the lower extremities to the heart. It is designed to catch blood clots that form in the legs, called deep vein thrombosis, from reaching the heart and lungs. The device is intended to be removed once the risk of blood clots has subsided.
Three months after being implanted with a Cook Celect IVC filter, Kyle underwent surgery for doctors to remove the device. They noted that the device had tilted inside her inferior vena cava, from about 12 degrees to an angle of 32.3 degrees. Even more concerning was that the hook of the filter used to retrieve the device was imbedded in her large vein.
Doctors made several attempts to snare the top of the filter, but were unsuccessful. They eventually abandoned the procedure. A week later, doctors attempted the retrieval again, but again, they were unsuccessful. This time, the filter was turned completely on its side. One of the tips of the filter was embedded in Kyle’s inferior vena cava and another distally appeared to be eroded all the way through the vein. Doctors were only able to remove one wire leg of the filter.
A CT scan performed weeks later revealed that the struts of the filter had penetrated the wall of Kyle’s inferior vena cava and that the retrieval hook was in the left lateral wall.
Kyle’s is one of 4,000 cases pending in a multidistrict litigation in the Southern District of Indiana against Cook Medical over injuries plaintiffs claim they suffered from the alleged defective devices. The filters are prone to move or fracture inside the body and travel to organs like the heart or lungs, perforate the wall of the inferior vena cava, and linger in patient’s bodies posing further risks.
Cook isn’t the only medical device maker under fire for retrievable IVC filters. C.R. Bard, another manufacturer of IVC filters, faces more than 3,600 cases pending in a multidistrict litigation in the District of Arizona.
Source: U.S. District Court Southern District of Indiana